PIT

Leishmania Spp. Antigen Detection Assay

Product code: PIT
Device name: Leishmania Spp. Antigen Detection Assay
Device class: Class 1
21 CFR: 21 CFR 866.3870
Medical specialty: Microbiology
Marketing pathway: 510(K)
Flag: Third-party review eligible
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

An in vitro diagnostic test for the detection of Leishmania spp. antigens to aid in the diagnosis of Leishmania spp. infection.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: PIT

Classification and pathway per current FDA publications. Data from openFDA (CC0).